Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

Menu

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
My View
Tags:
Medical Device

Medtronic Warning Letters Lifted, Clearing Path For CRM, Neurostim PMAs

This article was originally published in The Gray Sheet

  • News

Executive Summary

A barrier to FDA approval for several of Medtronic's core product candidates was lifted with the firm's announcement March 9 that longstanding warning letters had been resolved.

You may also be interested in...



FDA To Meet With Medtronic On Drug Pump Risks; Warning Letter Sent

The agency posted a warning letter to Medtronic Aug. 21 citing the firm for multiple quality system deviations, including lapses in its efforts to address a failure risk for the SynchroMed II drug infusion pump.

New Products In Brief

Medtronic’s Protecta

New Products In Brief

Medtronic’s Protecta

Table

View full table

Topics

Tags:
Medical Device
Latest Headlines

GE HealthCare Launches AI-Powered Voluson Ultrasound For Women’s Health

FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility

‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports

Lilly Can Rest Easy As Tirzepatide Scores Phase III Sleep Apnea Win

See All
UsernamePublicRestriction

Register

MT029937

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By